BriaCell Therapeutics Corp. announced that it has received agreement and positive feedback from its End of Phase II meeting with the FDA regarding BriaCell's lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic breast cancer. BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell's upcoming pivotal clinical study.

This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist. Registration study success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer.